Latest articles Pharma & Vaccines

Kalydeco (ages 2 - 5) & Orkambi (ages 12+) are variations on a new style of drug to fight Cystic Fibrosis (CF) that treat the underlying protein misfire rather than simply treating the symptoms. It is made by a pharmaceutical company that makes you want to take the sort of full body decontamination scrub normally reserved for exposure to anthrax - Vertex Pharmaceuticals.

Activist Post: Vaccines have been tested for safety individually. They have never been tested for safety in the combination that we are giving them to our kids. Now a review of the CDC's VAERS database clearly shows that kids are being harmed and killed. In fact a half a million reports. We must have a review of the safety of vaccines.

FreeThoughtProject: Of the nearly 12,000 pregnant women with clinical symptoms of Zika infections until March 28, no cases of microcephaly were reported as of May 2. In February we reported that doctors in Brazil and Argentina sounded the alarm over Monsanto's pyriproxyfen, which is used for mosquito control by targeting the larval stage. This chemical was sprayed in the areas most affected by microcephaly, but more significantly, was added to drinking water in the Brazilian state of Pernambuco (where the outbreak was at it's worst).

Two drug companies, Genentech and OSI Pharmaceuticals, have agreed to pay $67 million to settle a whistleblower lawsuit accusing them of misleading doctors about the effectiveness of a cancer drug called Tarceva. – By agreeing to the settlement, neither company admitted any guilt.

NaturalSociety: Genentech and OSI caught encouraging Doctors to prescribe Tarceva for cancers that it was not suitable for, and they knew that. In this unprincipled greed, sufferers lost their one chance at an effective treatment by being prescribed a drug that the companies knew would not work.

Tools

Pharmaceuticals

The Liberty Campaign is essentially a Libertarian philosophy. We believe that left to itself the free market will provide the best quality product or service at the best price. Wherever the free market is failing, it is not Capitalism that is at fault, it is Government regulation. The cost of new drug development and the regulation of the medical industry provides such high barriers to entry that the drug companies have an oligopoly. That corruption of the free market leads to criminal behaviour - why - because they can.

It is a truism that Drug Companies do not have patients, they have profit centres. There is no incentive on Big Pharma to cure anyone, nor indeed to let them die. Maximum profits come from the place in between - moderating symptoms while preserving the underlying condition. In other words, repeat business.

Medications like Cannabis Oil actually cure conditions that Big Pharma only moderates, which is why it is illegal and has been accompanied by a long tradition of demonisation, so anyone suggesting review of the ban is dismissed as a stoner/loser. The internet has intervened in this situation, with Facebook especially to the fore. Facebook groups such as those we mention in the news box highlight real people who have used alternative therapies to cure rather than treat a condition. This represents a huge threat to Big Pharma, and to the politicians who enjoy millions of dollars in annual bribes to defend the interests of the industry.

Big Pharma also have some real problems themselves. Major drug patents are expiring at the same time, about now. There are no new drugs on the horizon to replace them. See the second article in the tabs below. So Big Pharma is getting desperate and the provisions in the TPP to extend drug patents were their main hope for a financial lifeline. Having failed in that move Big Pharma are taking marginal sales, such as selling Oxycontin (synthetic heroin) to kids as young as 11.

Liberty Campaign believe that the Australian Government should create a new corporation spun off the CSIRO with responsibility to develop, grow and market alternative treatments like Cannabis Oil. The shares should be vested in the Future Fund and a 50.1% Australian Ownership rule respected. This will create new wealth for Australians while lowering health costs and improving health care options. It would give average Australians an opportunity to purchase products like Cannabis Oil from a source they can trust.

Here is a further review of the state of Big Pharma from the BBC. Please click the headling to see the article.

BBC: Extreme Profits and Bad Behavior

Imagine an industry that generates higher profit margins than any other and is no stranger to multi-billion dollar fines for malpractice. Throw in widespread accusations of collusion and over-charging, and banking no doubt springs to mind. In fact, the industry described above is responsible for the development of medicines to save lives and alleviate suffering, not the generation of profit for its own sake. Pharmaceutical companies have developed the vast majority of medicines known to humankind, but they have profited handsomely from doing so, and not always by legitimate means.

Last year, US giant Pfizer, the world's largest drug company by pharmaceutical revenue, made an eye-watering 42% profit margin. As one industry veteran understandably says: "I wouldn't be able to justify [those kinds of margins]."Stripping out the one-off $10bn (£6.2bn) the company made from spinning off its animal health business leaves a margin of 24%, still pretty spectacular by any standard. In the UK, for example, there was widespread anger when the industry regulator predicted energy companies' profit margins would grow from 4% to 8% this year.

Last year, five pharmaceutical companies made a profit margin of 20% or more - Pfizer, Hoffmann-La Roche, AbbVie, GlaxoSmithKline (GSK) and Eli Lilly

'Profiteering'With some drugs costing upwards of $100,000 for a full course, and with the cost of manufacturing just a tiny fraction of this, it's not hard to see why. Last year, 100 leading oncologists from around the world wrote an open letter in the journal Blood calling for a reduction in the price of cancer drugs. Dr Brian Druker, director of the Knight Cancer Institute and one of the signatories, has asked: "If you are making $3bn a year on [cancer drug] Gleevec, could you get by with $2bn? When do you cross the line from essential profits to profiteering?"

And it's not just cancer drugs - between April and June this year, drug company Gilead clocked sales of $3.5bn for its latest blockbuster hepatitis C drug Sovaldi. Drug companies justify the high prices they charge by arguing that their research and development (R&D) costs are huge. On average, only three in 10 drugs launched are profitable, with one of those going on to be a blockbuster with $1bn-plus revenues a year. Many more do not even make it to market.But as the table below shows, drug companies spend far more on marketing drugs - in some cases twice as much - than on developing them. And besides, profit margins take into account R&D costs.

The industry also argues that the wider value of the drug needs to be considered."Drugs do save money over the longer term," says Stephen Whitehead, chief executive of the Association of the British Pharmaceuticals Industry (ABPI). "Take hepatitis C, a shocking virus that kills people and used to require a liver transplant. At £35,000 [to £70,000] for a 12-week course, 90% of people are now cured, will never need surgery or looking after, and can continue to support their families. "The amount of money saved is huge."

True, but just because you can charge a high price for something does not necessarily mean you should, especially when it comes to health, critics such as Dr Druker might say. Shareholders, who big pharma companies ultimately have to answer to, would have little time for such an argument.

No loyaltyBig pharma companies also say they only have a limited time in which to make profits. Patents are generally awarded for 20 years, but 10-12 of those are typically spent developing the drug at a cost of about $1.5bn-$2.5bn.This leaves eight to 10 years to make money before the formula can be taken up by generic drug companies, which sell the medicines for a fraction of the price. Once this happens, sales fall by 90%-plus. As Joshua Owide, director of healthcare industry dynamics at research company GlobalData, explains, "Unlike other sectors, brand loyalty goes out the window when patents expire."

This is why pharma companies go to such extraordinary lengths to extend their patents - a process known as evergreening - employing "floors full of lawyers" for this express purpose, one industry insider says. For a drug raking in $3bn a quarter, even a one-month extension can be worth huge sums of money. New formulations, combining two existing drugs to give a wider use, and enantiomers - a mirror image of the same compound - are some of the legal ways to eke out patents. But some drug companies, including the UK's GSK, have been accused of more underhanded tactics, such as paying generics to delay the release of their cheaper alternatives. As the loss of sales at the big pharma companies far outweighs the revenue made by the generics, this can be an attractive arrangement for both parties.

Courting doctorsBut drug companies have been accused of, and admitted to, far worse. Until recently, paying bribes to doctors to prescribe their drugs was commonplace at big pharmas, although the practice is now generally frowned upon and illegal in many places. GSK was fined $490m in China in September for bribery and has been accused of similar practices in Poland and the Middle East. The rules on gifts, educational grants and sponsoring lectures, for example, are less clear cut, and these practices remain commonplace in the US.

Indeed a recent study found that doctors in the US receiving payments from pharma companies were twice as likely to prescribe their drugs. This may well exacerbate the problem of overspending on drugs by governments. A recent study by Prescribing Analytics suggested that the UK's National Health Service could save up to £1bn a year by doctors switching from branded to equally effective generic versions of the drugs.

This all may change when new rules in the US and UK will force doctors to disclose all gifts and payments made by the industry. Drug companies have also been accused of colluding with chemists to overcharge for their medicines and of publishing trial data that highlight the positive at the expense of the negative. They have also been found guilty of mis-branding and wrongly promoting various drugs, and have been fined billions as a result. The rewards are so great, it would seem, that pharma companies have continually been prepared to push the boundaries of legality.

'Undue influence'

No wonder, then, that the World Health Organisation (WHO) has talked of the "inherent conflict" between the legitimate business goals of the drug companies and the medical and social needs of the wider public. Indeed the Council of Europe is launching an investigation into "protecting patients and public health against the undue influence of the pharmaceutical industry". It will look at "particular practices such as sponsoring health professionals by the industry... or recourse by public health institutions to the knowledge of highly specialised researchers on the pay-rolls of industry". No matter what the outcome of such investigations, however, the pharmaceutical industry is facing fundamental change, as the traditional model of developing drugs breaks down due to rising costs and scientific advances. The cosy world of big pharmaceuticals is under threat like never before. This is the first in a two-part series on pharmaceutical companies. The second looks at how and why fundamental change will take place in the industry.

BBC: Pharmaceuticals industry facing fundamental change

Pharmaceuticals is an extraordinarily profitable business. The most profitable, in fact, looking at figures for last year. But for how much longer is the question occupying the minds not just of big pharma executives, but of health professionals and governments the world over. There are already signs of trouble ahead - thousands of job losses and widespread consolidation are hardly characteristics of an industry in rude health. But this is just the beginning of a process that could fundamentally change the pharmaceutical sector forever.

'Little breakthrough'

For a start, big pharmaceutical companies are no longer providing the service they once did."The system has served us well in terms of developing good new medicines, but in the past 10-20 years there has been very little breakthrough in innovation," says Dr Kees de Joncheere at the World Health Organisation.Of the 20 or 30 new drugs brought to the market each year, "many scientists say typically three are genuinely new, with the rest offering only marginal benefits," he says.

This dearth of genuinely new potential blockbuster drugs is a grave problem for big pharmas, and of course society at large, particularly given the industry is falling off a patent cliff the like of which it has never seen."Over the past three or four years, we have seen the biggest collection of patent expiries in history," says Stephen Whitehead, chief executive of the Association of the British Pharmaceuticals Industry (ABPI). "This has cost the industry some £150bn ($240bn)."Also weighing heavily on pharma companies is the process known as stratification. Scientific advances have led to a far better understanding of both genetics and disease, which means individual drugs can now be targeted far more directly at a much smaller number of patients. Whereas previously one drug would be used to treat different types of cancer, for example, now different strains can be treated with a specific medicine.

The cost of developing these drugs remains high, typically $1.5bn-$2.5bn (£900m-£1.5bn), but the market for them is tiny - in some cases only 100-150 patients.

Fair price?

This all means drugs are becoming increasingly expensive, and prohibitively so in some cases. Gilead's new hepatitis C drug Sovaldi - costing upwards of $100,000 for a full course - has caused quite a stir.

"Increasingly questions are being asked," says Dr de Joncheere. "Are we getting a fair price? Are we getting enough transparency in research and development?"If France were to treat all its hepatitis C patients with Sovaldi, it would add €1.5bn ($1.9bn; £1.2bn) to the country's drugs bill."[These kinds of drugs] are just not affordable any more."And particularly so when fragile economic growth and high debt levels are squeezing government budgets across the world.

Even in the US, where free market pricing rules absolutely, Congress is becoming increasingly concerned about the price of some drugs.

Neglected drugs

And it's not just the cost of the drugs that are being developed that is a big problem, but those that aren't.Big pharma companies are in the business to make money, so will generally develop those drugs that offer the greatest potential for profit. This means a number of important drugs are neglected - the current Ebola crisis being a case in point. Previous outbreaks over the past 30-40 years have been nothing like as serious as that which has claimed thousands of lives in West Africa and threatens to spread to the more developed world. But the reason why there are so few drugs in the pipeline has more to do with affordability - developing economies do not have the kind of money needed to pay for what would be an expensive vaccine, and no amount of public pressure will override the profit-making incentive of the big pharma companies.The pharmaceutical industry had been slow to develop an Ebola vaccine before the recent outbreak.

Antibiotics is another example. These vital anti-bacterial drugs have been virtually ruined by trigger-happy GPs and patients who don't stay the full course. Resistance has built up to such a degree that, soon enough, these drugs will no longer be fit for purpose. But new antibiotics would need to be affordable, or restricted to those that truly need them. Either way, there is little incentive for private companies to enter the market.

As Dr Stephen Godwin, senior research director at the Planning Shop International, says, "If you're only using it for seven to 10 days, it's a whole lot more difficult to make a profit than on a medicine people have to take every day."

Radical change

No wonder, then, that "the [current] model has run out of steam" as Dr de Joncheere puts it. Big pharma companies are facing a huge drop in revenue from blockbuster drugs coming off patent, while those increasingly difficult-to-find replacements are simply becoming too expensive. And without generating revenues through sales, these companies will struggle to fund the development of new life-saving drugs.

Big pharma facts

Total global spending on medicines will exceed $1 trillion for the first time in 2014.

Global spending on prescription medicines is expected to increase by $205bn-$235bn in the five years to 2017.

The US, EU5 (Germany, France, Italy, UK and Spain), Japan and China account for just under 70% of total global medicine spending.

In 2012 in developed economies, 72% of all spending was on branded drugs, with 16% on generics.

Spending on traditional pharmaceuticals in emerging markets is expected to rise by 69% over the next five years.

Source: IMS Health

In the UK, the ABPI negotiates with the government to agree a cap on the National Health Service drugs bill - this year and next there will be no rise. But longer term, more radical approaches will be needed. One obvious solution, which is already taking hold, is pharma companies working in partnership with government - a great deal of work has already been done to help in the fight against Aids, malaria, meningitis and tuberculosis, for example, while work on developing new antibiotics is under way. They will also have to work more closely with each other, a process that has begun already with the multi-billion-dollar deal struck earlier this year between Novartis and GlaxoSmithKline.

Raising money on financial markets, for example through long-term bonds, will also be needed to plug funding gaps.

Both national governments and multi-national bodies such as the European Commission will have to devote more resources to fund research and development, rather than relying on the private sector, while third parties such as the Bill Gates Foundation will have a bigger role to play alongside the charitable sector.

Collaboration and partnership, then, may have to take the place of profit and competition as the key words in the development of the medicines of the future. And that may be no bad thing for all of us.

There is overwhelming evidence that the active ingredient in Medical Cannabis, commonly called Cannabinoids have tremendous therapeutic benefits across a range of diseases. Here is a summary of the current state of the science.

NOTE: Beyond mainstream, allopathic, medicine there is a plethora of cannabis oil, cancer cure testimonials on the internet and the success stories keep pouring in each and every day.

Paul Fassais a contributing staff writer for REALfarmacy.com. His pet peeves are the Medical Mafia’s control over health and the food industry and government regulatory agencies’ corruption. Paul’s valiant contributions to the health movement and global paradigm shift are world renowned. Visit his blog by following this link and follow him on Twitter here.

Legality of Cannabis by Country

Vaccines

We support vaccination, but not vaccines. HUH? Vaccines are being produced to the lowest price possible by big Pharma who have a track record of dishonesty (see "Big Pharma Big Fines" below). They can hide behind this mask of good intentions and rely on the lamestream media and Doctor's groups to defend them against criticism. In this picture then what incentive do they have to do the right thing, and produce clean vaccines? The answer is none at all. Yet the fund that compensates kids who have been poisoned by defective vaccines has paid out over USD $3 billion in compensation, so we know the vaccines are not safe. The Liberty Campaign strongly supports a Royal Commission into the purity of vaccines currently available.